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Diagnosing MASH

Testing for metabolic dysfunction-associated steatohepatitis (MASH) and metabolic dysfunction-associated liver disease (MASLD)

There is currently an unmet need regarding MASH and MASLD: Non-invasive tests for screening, diagnosis, staging and monitoring therapeutic response to these diseases.

We are helping change this. In September 2020, Labcorp and GENFITTM—a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and liver diseases—announced an agreement to license a new technology—NIS4—to help identify patients with at-risk metabolic dysfunction-associated steatohepatitis (MASH). In May 2021, Labcorp launched NASHnext™, a novel, noninvasive diagnostic test for MASH. The test, offered exclusively in the U.S. and Canada through Labcorp, is powered by NIS4™, GENFIT’s proprietary diagnostic technology that uses a novel, blood-based molecular biomarker test to identify MASH and significant fibrosis (also referred to as “at-risk NASH”) in patients with at least one metabolic risk factor. In addition, Labcorp offers numerous tests specifically designed to help physicians with their diagnoses of MASH and MASLD.

Featured MASLD and MASH testing offered by Labcorp

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Enhanced Liver Fibrosis (ELF™)

The Enhanced Liver Fibrosis (ELF™) blood test is a simple, accurate, non-invasive test that provides a simple, unitless numeric score that is generated via an algorithm for use in advanced liver fibrosis. It is indicated as a prognostic marker in conjunction with other laboratory findings and clinical assessments in patients with advanced fibrosis (F3 or F4) due to non-hepatitis (NASH) to assess the likelihood of progression to cirrhosis and liver-related clinical events. Because ELF™ uses a blood sample rather than a biopsy, it can be used routinely for the same patient over time.

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FIB-4

FIB-4 index is reported to be a simple, accurate, non-invasive, and readily available laboratory test index that can help in evaluation of patients with HCV and Non-Alcoholic Fatty Liver Disease (MASLD) for the presence of liver fibrosis indication for liver biopsy, and other liver-related complications. It was also reported to be concordant with FibroSure test results.

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FIB-4 With Reflex to Enhanced Liver Fibrosis (ELF)™

Based on AACE recommendations, see individual assay descriptions FIB-4 index is calculated first; if FIB-4 index value is between 0 and 1.29, testing stops; if FIB-4 index value is greater than 1.29, testing is reflexed to ELF.

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FIB-4 w/Reflex NASH FibroSure® Plus

Based on AACE recommendations, see individual assay descriptions FIB-4 index is calculated first; if FIB-4 index value is between 0 and 1.29, testing stops; if FIB-4 index value is greater than 1.29, testing is reflexed to ELF.

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NASH Fibrosure® Plus

This test is a noninvasive assessment of liver status in patients with nonalcoholic fatty liver disease (MASLD). Quantitative results of 10 biochemicals in combination with age, gender, height, and weight are analyzed using a computational algorithm to provide a quantitative surrogate marker (0.0-1.0) of liver fibrosis (Metavir F0-F4), hepatic steatosis (0.0-1.0, S0-S3), and nonalcoholic steatohepatitis (NASH) (0.0-0.75, N0-N2). The absence of steatosis (S<0.38) precludes the diagnosis of MASH.

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NASH FibroSure® Plus With Reflex to Enhanced Liver Fibrosis (ELF) ™

This test combines NASH FibroSure® Plus with potential reflex to the Enhanced Liver Fibrosis (ELF™) test. NASH FibroSure® Plus provides a noninvasive assessment of liver status in patients with metabolic-associated steatotic liver disease (MASLD), analyzing 10 biochemicals with age and gender to generate quantitative markers for liver fibrosis, hepatic steatosis, and MASH.

If reflex testing is performed, the ELF™ test provides a prognostic marker for patients with advanced fibrosis due to NASH/MASH to assess the likelihood of progression to cirrhosis and liver-related clinical events.

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NASHnext™

Utilizing NIS4™ technology, NASHnext™ is a blood-based diagnostic test that quantitatively measures four independent biomarkers to produce a score that identifies, among patients with metabolic factors, those with at-risk NASH, who are at higher risk of disease progression.

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More accurate results. Fewer invasive procedures. Better outcomes. 

In addition to diagnostic tests that aim to identify MASH and MASLD, Labcorp can provide you and your patients with testing that can help identify underlying MASH and MASLD risks. From hepatitis to cardiovascular disease, Labcorp can assist with your diagnostic testing needs. 

Labcorp can help meet your MASLD-MASH needs

Contact a Labcorp representative to learn more about how we can help meet your MASH and MASLD testing needs.